Late-Stage Clinical Applications Writer
7 days ago
We are looking for a highly skilled Late-Stage Clinical Applications Writer to join our team at RBW Consulting. In this role, you will be responsible for writing CMC sections of regulatory submissions, including Modules 2.3 and 3 of the CTD, and briefing documents for Health Authority consultations.
Key Responsibilities:- Write CMC sections of regulatory submissions, including Modules 2.3 and 3 of the CTD, and briefing documents for Health Authority consultations.
- Collaborate with CMC teams (formulation, process development, analytical, and manufacturing) to gather necessary information.
To succeed in this role, you will need a strong background in technical writing, with at least 5 years of experience in CMC regulatory submissions. You should also have in-depth knowledge of CMC-related regulatory requirements and guidelines (e.g., ICH, FDA, EMA) and experience with eCTD submissions.
The salary range for this position is $90,000 - $110,000 per year, depending on experience. As a fully remote role with occasional travel to the R&D Centre in Paris, France, you will have the flexibility to work from anywhere while contributing to the development of groundbreaking therapies.
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Technical Writer
7 days ago
Nationwide, United Kingdom RBW Consulting Full timeTechnical Writer – Analytical CMC Are you a detail-oriented technical writer with a passion for regulatory science and analytical development? Join a dynamic Regulatory Department as a Senior CMC Regulatory Technical Writer. In this pivotal role, you will be instrumental in preparing and submitting high-quality CMC regulatory documents to support...
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Technical Writer
1 month ago
Nationwide, United Kingdom RBW Consulting Full timeTechnical Writer – Analytical CMC Are you a detail-oriented technical writer with a passion for regulatory science and analytical development? Join a dynamic Regulatory Department as a Senior CMC Regulatory Technical Writer. In this pivotal role, you will be instrumental in preparing and submitting high-quality CMC regulatory documents to support...
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Nationwide, United Kingdom RBW Consulting Full timeKey Responsibilities:Prepare, review, and finalize regulatory submission documents for late-stage clinical applications (Phase 3) and marketing applications.Write CMC sections of regulatory submissions, including Modules 2.3 and 3 of the CTD, and briefing documents for Health Authority consultations.Collaborate with CMC teams (formulation, process...
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Senior Technical Writer
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Senior CMC Regulatory Document Specialist
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